Passionate about IP! Since June 2003 the IPKat has covered copyright, patent, trade mark, info-tech, privacy and confidentiality issues from a mainly UK and European perspective. The team is Neil J. Wilkof, Annsley Merelle Ward, Nicola Searle, Eleonora Rosati, and Merpel, with contributions from Mark Schweizer. Read, post comments and participate! E-mail the Kats here

The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

And what a document it is. It still has onerous "due diligence" provisions (Article 4(2)) for users of genetic material, which seem to this Kat completely out of proportion to the issue. If no "internationally recognised certificate of compliance is available", then users are required to "seek, keep and transfer to subsequent users" "information and relevant documents on":

(i) the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;
(ii) the description of the genetic resources or of traditional knowledge associated with genetic resources utilised;
(iii) the source from which genetic resources or traditional knowledge associated with genetic resources were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;
(iv) the presence or absence of rights and obligations related to access and benefitsharing including rights and obligations regarding subsequent applications and commercialisation;
(v) access permits, where applicable;
(vi) mutually agreed terms, including benefit-sharing arrangements, where applicable.

But, for this Kat, the most welcome and important thing is that the Regulation should only apply to genetic resources accessed AFTER the entry into force of the Nagoya Protocol for the EU (Article 2(1)). This means that the effects, however unwelcome, should be manageable.

The document is a hideous chimera that not even its mother could love. It defines the term "illegally accessed genetic resources" (Article 3(8a)) purely for show, because the term is never used in the draft Regulation. Sensibly, the term "user" and "utilisation" of genetic resources is defined in Article 3 consistently with the Nagoya Protocol itself:

(5) "user" means a natural or legal person utilising genetic resources or traditional knowledge
associated with genetic resources;
(6) "utilisation of genetic resources" means to conduct research and development on the
genetic and/or biochemical composition of genetic resources, including through the
application of biotechnology as defined in Article 2 of the Convention;

But this definition is actually very odd - where else in human discourse does "use" mean "research"? And since the fair and equitable benefit sharing with the provider of the genetic resources (which is the whole purpose of Nagoya) is clearly not limited to the benefit of the research per se, but rather to the benefit of subsequent commercialisation, the document hangs together badly. Moreover, in order presumably to resist the Parliament's attempt to define "user" more broadly, we now have to have a Recital 10d to say :

It is important that the new definitions contained in the Regulation, which are not included in the Convention or in the Nagoya Protocol, are consistent with the definitions of the Convention or the Nagoya Protocol. In particular the term “user” should be consistent with the Nagoya Protocol term “utilisation of genetic resources”.

This really should not have to find its way into the final document.

One of the few of Parliament's many odd Recitals which has survived is Recital 4a:

Genetic resources should be preserved in situ and utilised in sustainable ways and the benefits arising from their utilisation should be shared fairly and equitably. This would contribute to poverty eradication and, thereby, to achieving the United Nations Millennium Development Goals, as acknowledged in the preamble of the Nagoya Protocol. The implementation of the Nagoya Protocol should also aim to realise that potential.

This Kat suggests that anyone who considers that the Nagoya Protocol will "contribute to poverty eradication" has severely over-estimated the potential value of research based on existing genetic material. The opposite effect of the Nagoya Protocol, that "bioprospecting" will simply become economically unattractive and decrease, does not seem to have been contemplated. After all this it may turn out that there is in the end no benefit to share. That would be unfortunate and very sad indeed.

This Kat welcomes that the compromise document has resisted temptation to make patent application a check-point for compliance with Nagoya - instead the main check-points are receipt of research funding and product authorisation.

This Kat's understanding is that if Parliament votes to agree the compromise text, then this is what will be adopted as the Regulation. He will continue to dispatch Merpel to prowl around seeking developments, but if our dear readers have any news, the IPKat will be grateful to hear it.

7 comments:

Tim Roberts
said...

Thanks for this.

To speculate: presumably this is the final form of the Regulation. As one or two of the more ridiculous proposals of the Parliament have been taken out, the Environmental Committee is not conceding yet, but it seems improbable that the Council and Commission will give further ground.

It could be worse (yes, honestly!). It's not been made retrospective. There is no specific mention of criminal sanctions. And above all there is no requirement (yet) that every time you file a patent application mentioning a genetic resource, you have to mention its country of origin.

But the scope of the Regulation is worryingly broad. It's not just 'bioprospecting'. It covers (doesn't it?) all research on non-human genetic resources. When Nagoya comes into force (later this year) all research on such genetic resources will become prima facie unlawful. To make it lawful, you will have to show, either that you have had the GR from before Nagoya came into force, or that you have the appropriate permissions from the 'country of origin' (for which purpose you are going to have to know what the 'country of origin' is).

And patent attorneys are going to have to explain this to their clients.

Would there be any interest in the IPKat hosting an evening discussion on the subject in London? I'd be delighted to take part and it might be rather interesting. I come at this subject from a different direction and while I broadly agree with much that is said by Darren in his various posts there are some matters about which there could be some constructive debate that might possibly interest more than the 2-3 people who have been commenting so far.

Thanks, Graham -- and I have some positive news for you. The IPKat is happy to organise just such a discussion. Kate Chapman (CGIAR) is happy to participate, as is Neil Wilkof. It would be great to involve you too. Watch this space!

Thanks for this - it is about the only article I could (easily) find on it! If the discussion event occurs, please let me know (charis@garnetcommunity.org.uk, though I am a twitter follower so should keep up) - I would be happy to help spread the word to UK plant scientists, it is important for them to be aware of the new regulations.

Dear all,You may be aware that the EU draft Regulation on ABS was approved by the European Parliament’s Environment Committee on 22 January 2014. However, it is not easy to find the link to the most recent version of the text, which is why I am taking the liberty to posting it here: http://www.europarl.europa.eu/meetdocs/2009_2014/documents/envi/dv/envi20140122_abs_agreed_text_/envi20140122_abs_agreed_text_en.pdf

This text will be voted by the EU Parliament on 11 March 2014, with a view to its adoption the same day the Nagoya Protocol will come into force.If you are still planning to organise a discussion in London on this topic, I would be happy to contribute to it as well. I could usefully share some insights on the French experience in this regard. In particular, the Parliament is about to vote a law on access to genetic resources and associated TK which will be applicable to France and (some of) its overseers dependencies.

IPKat Policies

This page summarises the IPKat policies on guest submissions and comments. If you have posted a comment to one of our blogposts and it hasn't appeared, it may be because it doesn't match our criteria for moderation. To learn more about our guest submissions, comments and complaints policy and the procedure for lodging a complaint click here.

Has the Kat got your tongue?

Just click the magic box below and get this page translated into a bewildering selection of languages!